What BioAegis Therapeutics does

BioAegis Therapeutics is a clinical-stage private biotechnology company developing therapeutics for infectious, inflammatory, and degenerative diseases based on a proprietary recombinant form of human plasma gelsolin (rhu-pGSN). The company's platform centers on plasma gelsolin (pGSN), an abundant naturally occurring human blood protein that regulates the innate immune response by modulating NLRP3 inflammasome activation, enhancing pathogen uptake and killing by immune cells, binding inflammatory mediators and toxic actin, and shifting macrophages from an inflammatory (M1) to a healing (M2) phenotype. BioAegis' lead candidate is positioned as a non-immunosuppressive anti-inflammatory therapy, distinguishing it from conventional biologics that suppress immune function and leave patients vulnerable to infection.

The company's lead product rhu-pGSN is currently being evaluated in two Phase 2 clinical programs: BTI-203, a 600-patient global Phase 2b study for moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) enrolling across 75 sites in 13 countries, and BTI-204, a Phase 2 study for inflammasome-driven decompression sickness (DCS) conducted in collaboration with the University of Maryland School of Medicine under a US Navy contract. BioAegis holds an exclusive worldwide license to plasma gelsolin IP developed at Harvard-Brigham and Women's Hospital by Thomas P. Stossel, covering over 40 granted patents globally, and has received two FDA Fast Track designations (ARDS in June 2025; DCS in August 2025).

The business model is biopharmaceutical product sales upon regulatory approval, with future distribution through hospital and healthcare system channels targeting ICU and critical care settings. The company is pre-revenue and currently funded through a combination of equity financings (most recently a $22M round led by a European institutional fund in March 2022) and non-dilutive government contracts including a $20M BARDA DRIVe award (October 2023) and a US Navy contract (June 2025). BioAegis projects a $50 billion pipeline market opportunity across multiple inflammatory disease applications, and in April 2026 announced a collaboration with Prenosis to apply AI-driven precision medicine to identify responder subpopulations within the ongoing ARDS trial.

Name

BioAegis Therapeutics

Legal name

BioAegis Therapeutics, Inc.

Website

https://bioaegistherapeutics.com

Company type

Private

Founded year

2011

Operating status

Operating

Headcount range

11–50 employees

Short description

BioAegis Therapeutics is a clinical-stage private biotech developing recombinant human plasma gelsolin (rhu-pGSN) as a non-immunosuppressive therapy for acute inflammatory diseases, currently advancing two Phase 2 programs for ARDS and decompression sickness across global hospital sites.

Ownership category

akta.pro rank

Product category

Biopharmaceutical Therapeutics

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Regenerative Immunology & Inflammation Modulation (pro-regenerative biologics) (HLAAAGAL)

akta.pro secondary industries

Recombinant Protein Therapeutics (enzymes, hormones, growth factors) (HLAAAAAB), Immunology & Autoimmune Specialty Pharmaceuticals (HLAIACAB)

Keywords

• Plasma gelsolin therapy
• Anti-inflammatory therapeutics
• Recombinant protein drugs
• Critical care biopharmaceuticals
• Innate immune regulators

Headquarters

HQ city

Morristown

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain

Revenue model

1. Pharmaceutical Product Sales: BioAegis is developing recombinant human plasma gelsolin (rhu-pGSN) as a therapeutic for inflammatory diseases. Once approved, the company will generate revenue through sales of its biopharmaceutical product, initially targeting acute conditions like ARDS and decompression sickness, with potential expansion into chronic inflammatory diseases.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

BioAegis is developing a platform of biopharmaceutical therapies based on recombinant human plasma gelsolin (rhu-pGSN), a recombinant form of a naturally occurring human blood protein that regulates innate immunity and inflammation. Its lead product candidate is being evaluated in Phase 2 clinical trials for Acute Respiratory Distress Syndrome (ARDS) and decompression sickness (DCS), with future expansion into chronic inflammatory diseases.

Product overview

BioAegis Therapeutics is a clinical-stage company developing a platform of therapies based on recombinant human plasma gelsolin (rhu-pGSN), a critical immune regulatory protein. The lead product candidate rhu-pGSN is currently being evaluated in two Phase 2 clinical programs: BTI-203 for Acute Respiratory Distress Syndrome (ARDS) and BTI-204 for Decompression Sickness (DCS). The company is also leveraging AI-driven precision medicine through a collaboration with Prenosis to identify patient subpopulations most likely to benefit from gelsolin therapy.

Differentiator

Problem solved

Functional benefit

Products and services

• Recombinant Human Plasma Gelsolin (rhu-pGSN)
• BTI-203 (rhu-pGSN for Acute Respiratory Distress Syndrome)
• BTI-204 (rhu-pGSN for Decompression Sickness)

Quantifiable outcome

• ARDS affects over 500,000-700,000 patients per year in the US (approximately 10% of all ICU admissions) with approximately 40% mortality rate for severe cases
• +2 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Three partnerships are on record, tiered core.

• University of Maryland School of MedicinecoreStrategic or Co-development Partner · 1 January 2025Collaboration with Dr. Stephen Thom, Professor of Emergency Medicine at UMSOM, for Phase 2 study of rhu-pGSN for decompression sickness. This is the culmination of an extended collaboration on the role of the NLRP3 inflammasome in DCS and the therapeutic potential of plasma gelsolin.
• PrenosiscoreStrategic or Co-development PartnerStrategic collaboration announced April 2026 to advance AI-driven precision medicine in inflammatory disease. The partnership focuses on identifying biological signatures and patient subpopulations most likely to benefit from recombinant human plasma gelsolin (rhu-pGSN). This will leverage data from the ongoing 600-patient global Phase 2 ARDS trial to uncover biomarkers and define patient subgroups for precision medicine in critical care.
• Harvard-Brigham and Women's HospitalcoreTechnology or IntegrationBioAegis has exclusive license to broad, worldwide intellectual property through Harvard-Brigham and Women's Hospital. This IP estate, developed by Thomas P. Stossel (discoverer of gelsolin), forms the foundation of BioAegis' technology platform with over 40 patents issued globally.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• InflaRx: Clinical-stage biotech developing anti-inflammatory biologics (e.g., vilobelimab/IFX-1, an anti-C5a monoclonal antibody) for severe inflammatory diseases including hidradenitis suppurativa and critical care indications. Closely comparable to BioAegis as a similarly-sized inflammation-biologics company targeting acute and chronic inflammatory diseases with high unmet need.
• AM-Pharma: Developer of recombinant human alkaline phosphatase for acute kidney injury and sepsis-related inflammation. Directly comparable as a recombinant protein therapeutics company targeting critical care inflammation, with Phase 2/3-stage clinical programs and a non-immunosuppressive mechanism.
• Inotrem: Clinical-stage biotech developing TREM-1 pathway inhibitors (e.g., nangibotide) for septic shock and acute inflammatory conditions. Highly comparable as a European inflammation-biologics company with critical-care sepsis/ARDS overlap and a similar clinical-stage profile.
• Revelation Biosciences (formerly Humanigen): Clinical-stage immunology company developing therapeutics for inflammation and immune-mediated diseases (formerly developing lenzilumab for CAR-T and COVID-19 ARDS). Comparable as an anti-inflammatory biologics developer that has worked on ARDS/inflammation indications.
• Edesa Biotech: Clinical-stage biotech developing immunomodulatory therapies for inflammatory diseases, including critical care indications. Comparable as a similarly-sized inflammation-focused company with clinical-stage assets.
• Mesoblast: Late-stage cell therapy company with remestemcel-L for acute respiratory distress syndrome (ARDS) and other inflammatory conditions. Comparable as a developer of an ICU-administered biologic therapy for ARDS, a directly overlapping indication with BioAegis's lead program.
• CytoSorbents: Commercial-stage company whose CytoSorb blood-purification device removes inflammatory mediators (cytokines, toxins) in critical care settings including sepsis and ARDS. Comparable as an inflammation-targeting critical-care therapy with overlapping ICU end users.

Broad incumbents

• Alexion / AstraZeneca Rare Disease: Established rare-disease biopharmaceutical company with a portfolio of recombinant protein therapeutics (e.g., Soliris, Ultomiris, Strensiq). Comparable as a much larger commercial-stage recombinant protein therapeutics company with biologics manufacturing, regulatory, and global commercialization infrastructure BioAegis would need to build.
• CSL Behring: Global leader in plasma-derived and recombinant therapeutics for inflammatory, immune and rare diseases. Comparable as a large, established plasma/recombinant protein therapeutic company with overlapping inflammatory-disease focus and broad ICU/hospital distribution capability.
• AbbVie: Global biopharmaceutical company with a dominant anti-inflammatory biologics portfolio (Humira, Skyrizi, Rinvoq) addressing chronic inflammatory diseases. Comparable as the broad incumbent benchmark for chronic inflammation indications BioAegis may pursue beyond ARDS/DCS.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/bioaegis
• YouTubeyoutube.com/channel/UC9AflH4d_CL1TZLTBwb21HA
• LinkedInlinkedin.com/company/bioaegis-therapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Funding overview

Funding rounds6 records

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about BioAegis Therapeutics